Pfizer to recall lot of Lipitor
NEW YORK — Pfizer on Monday announced that it intends to recall one lot — approximately 19,000 bottles — of Lipitor 40-mg tablets (atorvastatin calcium) distributed in the United States because of one customer’s report of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged.
The bottles were supplied by a third-party bottle manufacturer. A medical assessment found that the risk of health consequences to patients appears to be minimal, Pfizer reported.
The market action is the result of Pfizer’s increased surveillance of odor-related issues after other reports in the industry. This increased surveillance also led to three earlier recalls of Lipitor, implemented in August, October and November 2010, in response to infrequent complaints of uncharacteristic odor.
“We have identified the source of the odor, and we are enacting rigorous measures to prevent odor-related issues going forward,” Pfizer stated in a press release. “The lot that will be recalled was packaged and shipped before these changes went into effect in August of this year. As previously reported, product filled in bottles made by the supplier prior to those changes may still be on the market, so it is possible that additional recalls could be necessary.”
Pfizer does not anticipate a product shortage resulting from the recall.
AstraZeneca discontinues development of RSV drug
LONDON — An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.
AstraZeneca has requested the withdrawal of its pending biological license application for motavizumab from the Food and Drug Administration. Motavizumab is an investigational monoclonal antibody that could prevent serious respiratory syncytial virus disease.
AstraZeneca said it will incur a financial impairment charge of $445 million in fourth quarter 2010.
Court blocks AstraZeneca’s suits over Crestor
NEW YORK — A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.
Bloomberg reported that a judge from the U.S. District Court for the District of Delaware (Wilmington) said that the drug maker can’t use its patents expiring in 2018 and 2022 to prevent such companies as Mylan and Teva from developing generic versions of Crestor, since the patents only cover the methods of using the medicine. The generic drug makers are not required to put those uses on their labels, the judge said.
Back in June, AstraZeneca’s patent was upheld by the court, which protects Crestor from generic competition in the United States until 2016.